The Medasense Study
- Registration Number
- NCT01912118
- Lead Sponsor
- Leiden University Medical Center
- Brief Summary
Despite various efforts there is still the need for adequate monitoring of pain and nociception during anesthesia. In a previous protocol the investigators measured pain responses during anesthesia based on single end-points, eg heart rate,blood pressure and pulse transit time. None of these parameters provided sufficient information regarding nociception. The investigators therefore want to further investigate this matter using a composite parameter, the Nociception Level or NoL. The NoL is a novel index that measures the magnitude of the autonomic response to painful stimuli. The NoL combines information from several physiological parameters, which represent different autonomic pathways. The multi-parameter approach empowered with state-of-the-art signal processing and machine learning techniques. In the current study the investigators will measure the NoL in ASA 1-3 patients undergoing elective surgery under general anesthesia. The investigators will measure NoL responses and the occurrence of patient movement upon the administration of a painful stimulus: Introduction of the laryngoscope, Insertion of the endotracheal tube, Insertion of the gastric tube, Insertion of the bladder catheter and Skin incision.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
- Age: 18-80 years;
- Sex: male or female;
- Surgery: Any surgery under general anesthesia;
- ASA status: 1, 2 or 3.
- Age: < 18 or > 80 years;
- Unable to give written informed consent;
- Pregnancy/lactation;
- Extreme obesity: BMI > 35;
- Perceived difficult intubation.
- Patients requiring a rapid sequence induction
- Patients on beta-blockers
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PROPOFOL + REMIFENTANIL TARGET B Propofol The subject will be intubated according to the design of group 1. The propofol concentration will be 2-5 μg/kg, aimed at a BIS of 50, with 2 ng/ml remifentanil PROPOFOL + REMIFENTANIL TARGET E Remifentanil The subject will be intubated according to the design of group 1. The propofol concentration will be 2-5 μg/kg, aimed at a BIS of 50, with 5 ng/ml remifentanil. PROPOFOL ONLY GROUP Propofol In this study group measurements will be obtained before intubation or opioid administration. To that end plasma propofol concentration will be increased slowly from 0 to 4 μg/ml in steps of 0.5 μg/mL. After the highest target is reached, the propofol target concentration will be lowered to get a BIS value of 50. After 5-min, the laryngoscope will be inserted into the mouth. Next the laryngoscope will be removed. After 5-min the laryngoscope will be placed again and the patient will be intubated. This will be done without additional administration of muscle relaxant. PROPOFOL + REMIFENTANIL TARGET A Remifentanil The subject will be intubated according to the design of group 1. The propofol concentration will be 2-5 μg/kg, aimed at a BIS of 50, with 1 ng/ml remifentanil. PROPOFOL + REMIFENTANIL TARGET A Propofol The subject will be intubated according to the design of group 1. The propofol concentration will be 2-5 μg/kg, aimed at a BIS of 50, with 1 ng/ml remifentanil. PROPOFOL + REMIFENTANIL TARGET B Remifentanil The subject will be intubated according to the design of group 1. The propofol concentration will be 2-5 μg/kg, aimed at a BIS of 50, with 2 ng/ml remifentanil PROPOFOL + REMIFENTANIL TARGET C Propofol The subject will be intubated according to the design of group 1. The propofol concentration will be 2-5 μg/kg, aimed at a BIS of 50, with 3 ng/ml remifentanil. PROPOFOL + REMIFENTANIL TARGET C Remifentanil The subject will be intubated according to the design of group 1. The propofol concentration will be 2-5 μg/kg, aimed at a BIS of 50, with 3 ng/ml remifentanil. PROPOFOL + REMIFENTANIL TARGET D Propofol The subject will be intubated according to the design of group 1. The propofol concentration will be 2-5 μg/kg, aimed at a BIS of 50, with 4 ng/ml remifentanil. PROPOFOL + REMIFENTANIL TARGET D Remifentanil The subject will be intubated according to the design of group 1. The propofol concentration will be 2-5 μg/kg, aimed at a BIS of 50, with 4 ng/ml remifentanil. PROPOFOL + REMIFENTANIL TARGET E Propofol The subject will be intubated according to the design of group 1. The propofol concentration will be 2-5 μg/kg, aimed at a BIS of 50, with 5 ng/ml remifentanil. PROPOFOL TARGET BIS 30 + REMIFENTANIL TARGET C Propofol The subject will be intubated according to the design of group 1. The remifentanil target will be 3 ng/ml remifentanil. The propofol concentration will aim a BIS of 30. PROPOFOL TARGET BIS 30 + REMIFENTANIL TARGET C Remifentanil The subject will be intubated according to the design of group 1. The remifentanil target will be 3 ng/ml remifentanil. The propofol concentration will aim a BIS of 30. PROPOFOL TARGET BIS 70 + REMIFENTANIL TARGET C Propofol The subject will be intubated according to the design of group 1. The remifentanil target will be 3 ng/ml remifentanil. The propofol concentration will aim a BIS 70. PROPOFOL TARGET BIS 70 + REMIFENTANIL TARGET C Remifentanil The subject will be intubated according to the design of group 1. The remifentanil target will be 3 ng/ml remifentanil. The propofol concentration will aim a BIS 70.
- Primary Outcome Measures
Name Time Method Nociception level index (NoI) Between induction and first incision The NoL measures the magnitude of the autonomic responses to painful stimuli. The NoL combines information from several physiological parameters which represent different autonomic pathways.
- Secondary Outcome Measures
Name Time Method Cardiovascular parameters Between induction and first incision Individual pain related cardiovascular parameters, as heart rate, blood pressure and PPG wave amplitude.
Movement Between induction and first incision Visible occurence of movement during painfull stimuli.
Depth of anesthesia Between induction and first incision Depth of anesthesia is measured by a Bispectral Index monitor. Changes in depth of anesthesia will be recorded during painfull stimuli
Trial Locations
- Locations (1)
Leiden University Medical Center
🇳🇱Leiden, Netherlands